MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	75063
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A nurse reported an issue with a bioflo picc (v) 5fdl-55cm maximal barrier nursing kit.The picc line was placed in the patient's left, mid-thigh, femoral artery, due to svc compression.During initial placement, adequate blood return was achieved; however, approximately 3 hours after placement, the picc line was noted to be difficult to flush and would not give blood return.Both the purple and grey lumens were affected.A kub was performed and confirmed that the tip had not migrated so altepase was ordered for instilling in both lumens.After altepase, both lines had positive blood return; however, the gray lumen was still sluggish, prompting a second dose of altepase.Blood return could not be established after the second dose; therefore, it was assumed that there was an issue with the device, other than, or in addition to, possible clotting.Difficulty flushing the port and establishing blood return continued to be an issue.Blood return could be established with patient lying in right, recumbent position ; however, it was not possible if patient was in a low fowler's position.The rn believed that the line may be flipping or twisting in on itself, when the patient straightens his leg into a more midial position.A dye study was performed and everything appeared normal; however, a the device was retracted so 3cm was external and it was noted that the catheter felt "flat" between the 0cm mark and white securement wings.Ultimately, the decision was made to remove and kinks were located in two places, between 6-7cm and 7-8cm.It was determined to not replace the picc line.The patient did not experience any adverse effects or harm as a result of this incident.
Additional Manufacturer Narrative
Returned for evaluation was one dl bioflo picc.As received, the catheter was returned untrimmed.The catheter had a kink between 6 and 7 cm marks making it difficult to flush.There were no manufacturing non-conformances observed during sample review.The customer's reported complaint description is confirmed for fluid flow problem and catheter tubing kinked.A defintive root cause for the reported event cannot be determined.A potential root cause for kink in catheter tubing in situ is patient anatomy and peripheral placement in leg vs.Typical placement in arm, i.E.Tubing was kinked due to flexing of groin/hip.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 14135565
• Report Number: 1317056-2022-00072
• Device Sequence Number: 17700043
• Product Code: LJS
• UDI-Device Identifier: H965750631
• UDI-Public: H965750631
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 75063
• Device Lot Number: 5715861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 81 KG